Regulatory Affairs
Marketing authorisation applications, CTD and eCTD dossier compilation, variations, lifecycle maintenance, regulatory strategy and GMP documentation support.
MAACTD / eCTDVariationsStrategy
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MA Holding Services
Marketing authorisation holding, regulatory affairs, pharmacovigilance and Qualified Person services across Europe and international markets.
MAH Services
Pharmacovigilance
Qualified Person
Overview
A Local Legal Presence Without a Local Subsidiary
Placing a product on the European market requires an established marketing authorisation holder, a pharmacovigilance system with a qualified person, and a QP to certify each batch. Setting all three up in-house is slow and expensive for a first market entry.
We provide those functions as a service — holding the authorisation, running the safety system and certifying batches — so you can enter the market on your product’s timeline rather than your corporate structure’s.
At a Glance
- Regulatory affairs and CTD/eCTD dossiers
- Pharmacovigilance and EU-QPPV
- Qualified Person batch release
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalThree Regulatory Pillars
Complete coverage of the obligations that follow a marketing authorisation.
Pharmacovigilance
Adverse event collection and reporting, EU-QPPV provision, signal detection, PSUR preparation and safety database management.
Adverse EventsEU-QPPVSignal DetectionPSUR
Qualified Person
Batch certification and release, GMP oversight of manufacturing and testing sites, import certification and supplier audits.
Batch ReleaseGMP OversightImport Certification
Where This Applies
Common scenarios for MA holding services.
- First entry into a new market — Placing product without establishing a legal entity or hiring a local regulatory team.
- Transitional arrangements — Bridging cover while your own MAH structure and PV system are being established.
- Import and batch release — QP certification for product manufactured outside the destination territory.
- Ongoing lifecycle management — Variations, renewals and safety reporting maintained for the life of the authorisation.
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Next Step
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